BioFeedBack Breathing Training Influence Cardiac Autonomic Nervous System in Children With Cerebral-Palsy.
Recruitment status was: Not yet recruiting
The effect of breathing biofeedback training to influence the function of the cardiac autonomic nervous system at rest and in activity in children with cerebral palsy.
Cerebral palsy children suffer from a non-progressive damage of the brain. It is the most common injury that causes physical handicapped in childhood. There are a few researches that investigated the autonomic function in cerebral palsy children. Those researches found hyperactivity of the sympathetic autonomic system, including high resting heart rate compare to their typically developed pears. The recommended treatment for cerebral palsy is activity, muscle strengthening and mobility. The impairment in the autonomic system influences the everyday function and has correlation with secondary morbidity.
As far as we know there are no researches who investigated the following issues.
In this study we would like to:
- Describe the autonomic cardiac function, Breathing function, motor function and the correlation between them in children with cerebral palsy.
- Compare the autonomic cardiac function at rest in aerobic test and in diaphragmatic breathing.
- Test the influence of breathing training on Heart rate variability parameters at rest, in aerobic test right after the breathing training program and one month after, in children with cerebral palsy
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effect of Breathing Biofeedback Training to Influence the Function of the Cardiac Autonomic Nervous System at Rest and in Activity in Children With Cerebral Palsy.|
- Change from Baseline of Heart rate variability meaures at one and two months [ Time Frame: Change from Baseline at one and two months ]
- Change from Baseline of Forced Vital Capacity, Forced Expiratory Volume in one, Tidal Volume, [ Time Frame: Change from Baseline at one and two month ]
- Change from Baseline Sub maximal aerobic test on treadmill-Modified Naughton Protocol with Polar watch and transmitter. [ Time Frame: Change from baseline at one and two month later ]
- Change from baseline breathing rate, by biofeedback [ Time Frame: Change from baseline at one and two month later ]
- Change from baseline Gross Motor Function Measure [ Time Frame: Change from baseline at one and two month later ]
- Change from baseline Children Assessment of Participation and Enjoyment [ Time Frame: Change from baseline at one and two month later ]
- Change from baseline Autonomic function questionnaire [ Time Frame: Change from baseline at one and two month later ]
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Active Comparator: biofeedback training
usual treatment+12 treatment of biofeedback training
Other: Biofeedback training
usual treatment +12 biofeedback training
No Intervention: control
60 children with cerebral palsy age 6-11 who can walk and understand simple instructions.
Main outcome measures:
Heart rate variability using Polar watch and transmitter RS810CX.
Secondary outcome measures:
- Lung functioning using Sensormedics Vmax 29 spirometry:Forced Vital Capacity, Forced Expiratory Volume in one,Tidal Volume.
- Sub maximal aerobic test on treadmill-Modified Naughton Protocol with Polar watch and transmitter.
- Gross Motor Function Classification System
- Gross Motor Function Measure
- Functional Mobility Scale
- Children Assessment of Participation and Enjoyment
- Autonomic function questionnaire
Please refer to this study by its ClinicalTrials.gov identifier: NCT01872507
|Contact: Itai Berger, MDfirstname.lastname@example.org|
|Hadassah Medical Organization||Not yet recruiting|
|Jerusalem, Israel, 91240|
|Contact: Taly Amichai, BPT MsSc 97289257319 email@example.com|
|Sub-Investigator: Sagi Gavri, MD|
|Sub-Investigator: Avraham Weiss, MD|
|Sub-Investigator: Taly Amichai, BPT Msc|
|Sub-Investigator: Michal Katz-Leurer, PhD|
|Principal Investigator:||Itai Berger, MD||Hadassah Medical Organization|